Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Other: MORE-VR

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05034276

R44DA053848 (U.S. NIH Grant/Contract)

IRB_00141495

Details and patient eligibility

About

This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect feasibility, usability, and engagement data, for patients receiving medications for opioid use disorder (mOUD).

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• DSM-5 opioid use disorder diagnosis
• treated with medications for opioid use disorder (MOUD)

Exclusion criteria

• Mindfulness intervention experience (MBSR, MBRP)
• Active psychosis or high risk of suicidality
• Cognitive impairment (per self-report or report by clinician)
• Unwilling or unable to remain in MOUD treatment for duration of study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

MORE-VR

Experimental group

Description:

Mindfulness-Oriented Recovery Enhancement deployed over virtual reality.

Treatment:

Other: MORE-VR